FDA warns: Use of weight-loss and diabetes drugs may cause blindness

The FDA has issued a new directive requiring manufacturers of GLP-1 drugs (Ozempic, Wegovy, Mounjaro, Zepbound) to add a warning about an increased risk of a rare eye disease, NAION, which can cause sudden vision loss. The decision was made after reviewing 126 clinical trials, which found 6.4 cases per 100,000 patient-years compared to 3.8 in the placebo group.

The U.S. Food and Drug Administration (FDA) has published a new directive requiring manufacturers of weight-loss and diabetes drugs from the GLP-1 family (Ozempic, Wegovy, Mounjaro, Zepbound) to update safety labels and add a warning about an increased risk of a rare eye disease called NAION, which can cause sudden vision loss. The decision was made following a comprehensive review that began after a study in July 2024. A re-examination of 126 clinical trials found that patients taking these drugs are at a slightly higher risk: 6.4 cases per 100,000 patient-years compared to 3.8 in the placebo group. NAION is caused by impaired blood supply to the optic nerve and manifests as sudden vision loss or blurring in one eye. Risk factors include smoking, diabetes, high blood pressure, and kidney disease. The FDA recommends that patients continue treatment as usual but remain vigilant for changes in vision, and in case of symptoms, temporarily stop the medication and consult an ophthalmologist.